A Phase I/II Clinical Trial Study on Autologous Erythrocytes Derived Microparticles Packaging Methotrexate Peritoneal Perfusion in the Treatment of Malignant Ascites
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- ORR, Objective Response Rate
研究概览
简要总结
This study makes an observation over the objective response rate of autologous erythrocytes derived microparticles packaging methotrexate peritoneal perfusion and systemic therapy combination in the treatment of malignant ascites. All the participants will randomly receive the treatment of autologous erythrocytes derived microparticles packaging methotrexate peritoneal perfusion and systemic therapy combination or convention drugs peritoneal perfusion and systemic therapy combination.
详细描述
As a drug carrier, erythrocytes have their own advantages, such as high biocompatibility, high immune compatibility, simple structure and easy access. In this study, microparticles released from erythrocytes are used as the carrier of chemotherapy drugs and effectively kill tumor cells in malignant ascites. These microparticles can easily reach the tumor site and bring the drug into tumor cells, which can overcome the two main problems in normal chemotherapy: damage to normal cells and drug resistance of tumor cells.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 and ≤ 80 years of age
- •Histological confirmed gastric cancer, colorectal cancer, or ovarian cancer, tumor cells were detected by exfoliative cytology of peritoneal effusion, refractory or recurrent ascites of ovarian cancer were required, other kinds of cancer were not limited
- •Vital signs were stable, Karnofsky ≥ 70, life expectancy of more than 3 months
- •The hematopoietic function of bone marrow was normal without bleeding tendency (INR < 1.5), blood routine examination: HGB ≥ 90 g/L, WBC > 4.0 × 10^9/L (NEU ≥ 1.5 × 10^9/L), PLT ≥ 80 × 10^9/L
- •Liver function: STB ≤ 1.5 ULN, AST and ALT≤ 2.5 ULN (if the abnormity of liver function was mainly caused by tumor invasion, AST and ALT ≤ 5 ULN), ALP ≤ 1.5 ULN
- •Renal function: BUN and Cr ≤ 1.5 ULN, CCr ≥ 50mL/min
- •ECG and blood glucose level were normal
- •Patients or family members agreed to participate in the study and signed informed consent
- •No other serious heart and lung disease, etc.
排除标准
- •Pregnant or lactating women
- •Allergic constitution and multi-drug allergy
- •Serious heart, lung, liver and kidney dysfunction, decompensated heart, lung, kidney, liver and other major organs dysfunction or failure, poor blood glucose control, chemotherapy intolerance, combined intestinal obstruction
- •Concurrent severe infection
- •HIV positive, HBsAg and HBV DNA copy number positive (quantitative detection ≥ 1000 cps/mL), chronic hepatitis C blood screening positive (HCV antibody positive)
- •Cognitive impairment or poor chemotherapy compliance determined by investigator
- •Less than 4 weeks from the last clinical trial
- •Unsuitable for clinical trials determined by investigator
研究组 & 干预措施
Erythrocytes derived MPs containing MTX
Suspension of erythrocytes derived MPs containing MTX, qd×6, 6 units MPs a time , Two courses.
干预措施: Erythrocytes derived MPs containing MTX (Other)
convention drugs
Chemotherapeutic drugs, biologicals or traditional Chinese medicine.Dosage form, dosage, frequency and duration according to respective medicine instructions.
干预措施: convention drugs (Drug)
结局指标
主要结局
ORR, Objective Response Rate
时间窗: From assignment of the first subject to 2 months later after the last participant is recruited.
The percentage of subjects with total number of Complete Response (CR) + total number of Partial Response (PR)
次要结局
- DCR, Disease Control Rate(From assignment of the first subject to 2 months later after the last participant is recruited.)
研究者
Hui ting Xu，MD
Deputy Chief Physician
Hubei Cancer Hospital